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Generated: January 16, 2019

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Details for New Drug Application (NDA): 022122

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NDA 022122 describes VOLTAREN, which is a drug marketed by Glaxosmithkline Cons and Novartis and is included in four NDAs. It is available from seventeen suppliers. Additional details are available on the VOLTAREN profile page.

The generic ingredient in VOLTAREN is diclofenac sodium. There are forty-seven drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 022122
Applicant:Glaxosmithkline Cons
Ingredient:diclofenac sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 022122
Suppliers and Packaging for NDA: 022122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOLTAREN diclofenac sodium GEL;TOPICAL 022122 NDA Alvix Laboratories, LLC 15455-9565 15455-9565-1 1 KIT in 1 CARTON (15455-9565-1) * 100 g in 1 TUBE * .55 mL in 1 PATCH
VOLTAREN diclofenac sodium GEL;TOPICAL 022122 NDA Rebel Distributors Corp 21695-791 21695-791-00 100 g in 1 TUBE (21695-791-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength1%
Approval Date:Oct 17, 2007TE:ABRLD:Yes

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